Global Pharmacovigilance (PV) Scientist, Senior Manager

Initial Therapeutics, Inc.; Washington (District of Columbia); Hybrid; USD 140,000 - 210,000; Full time

Benefits offered by this job

Retirement plan

Medical/dental/vision benefits

Life and disability insurance

Flexible spending accounts

Discretionary bonus

Job summary

Amgen is seeking a Global Pharmacovigilance Senior Manager to oversee safety data assessment, reporting, and regulatory interactions across therapeutic areas. You will lead cross-functional teams and liaise with affiliates to ensure high-quality safety deliverables.

The role emphasizes inspection readiness, risk management strategies, and collaboration with GSO to support regulatory filings and pharmacovigilance operations.

Qualifications

• Doctorate or advanced degree with PV experience.
• Strong knowledge of safety data analysis and regulatory writing.
• Experience in coordinating cross-functional safety activities.

Responsibilities

• Directs planning, writing and review of safety reports.
• Oversees safety data management and signal detection activities.
• Collaborates with affiliates and internal partners on safety issues.
• Supports risk management and regulatory submissions.
• Ensures inspection readiness and audit responses.

Skills

PV leadership

Safety data analysis

Cross-functional collaboration

Regulatory writing

Clinical safety

Education

Pharmacovigilance Doctorate

PV Masters

Life sciences Bachelor

HS diploma

Job description

Job DescriptionJoin Amgens Mission of Serving Patients

At Amgen, if you feel like youre part of something bigger, its because you are. Our shared missionto serve patients living with serious illnessesdrives all that we do.

Since 1980, weve helped pioneer the world of biotech in our fight against the worlds toughest diseases. With our focus on four therapeutic areas Oncology, Inflammation, General Medicine, and Rare Disease we reach millions of patients each year. Amgen is advancing a broad and deep pipeline of medicines to treat cancer, heart disease, inflammatory conditions, rare diseases, and obesity and obesity-related conditions. As a member of the Amgen team, youll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives.

Our award-winning culture is collaborative, innovative, and science based. If you have a passion for challenges and the opportunities that lay within them, youll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career.

Global Pharmacovigilance Senior Manager

What you will do

Lets do this. Lets change the world. In this vital role you will work with the Therapeutic Safety Teams for safety assessment activities for medical/scientific operations.

Responsibilities:

• Directs the planning, preparation, writing and review of portions of aggregate reports
• Organize and direct liaison for activities with affiliates and other internal Amgen partner regarding products
• Supports and provides oversight to staff with regards to safety in clinical trials to: Review and provide input and support on study protocols, statistical analysis plans and other clinical study-related documents
• Review of AEs/SAEs from clinical trials as needed
• Review standard design of tables, figures, and listings for safety data from clinical studies
• Participate in development of safety-related data collection forms for clinical studies
• Participate in study team meetings as requested or needed
• Signal detection, evaluation, and management- Perform data analysis to evaluate safety signals and write up analysis results
• Documents work as required in the safety information management system
• Author Safety Assessment Reports and other safety documents and regulatory responses in collaboration with the GSO
• Search and review adverse event data, literature, and other safety-relevant data for the purpose of signal detection
• Prepare presentation of the Global Safety Teams recommendations on safety issues to the cross-functional decision-making body
• Assist GSO in the development of risk management strategy and activities:

• Provides contents for risk management plans
• Develop or update strategy and content for regional risk management plans
• Assist GSOs to oversee risk minimization activities including tracking of activities as needed.
• Evaluate risk minimization activity
• Prepare response to regulatory inquiries related to risk management plans under the guidance of GSO
• Support activities related to new drug applications and other regulatory filings: Assist GSO in developing a strategy for safety-related regulatory activities, Provide safety contents for filings
• Inspection Readiness
• Undertake activities delegated by the QPPV as detailed in the PV System Master File and maintain a state of inspection readiness
• Be representative and point of contact for Health Authority Inspection and Internal Process Audits within the remit of role and responsibility

What we expect of you

We are all different, yet we all use our unique contributions to serve patients. The pharmacovigilance professional we seek is a leader with these qualifications.

Basic Qualifications:

• Doctorate degree and 2 years of industry pharmacovigilance experience
• OR
• Masters degree and 4 years of industry pharmacovigilance experience
• OR
• Bachelor's degree and 6 years of industry pharmacovigilance experience
• OR
• Associates degree and 10 years of industry pharmacovigilance experience
• OR
• High school diploma/GED and 12 years of industry pharmacovigilance experience

Preferred Qualifications:

• BS in Life Science with 3 years drug safety experience, preferably industry pharmacovigilance experience
• Experience in Signal detection, evaluation and management
• Experience of Literature Surveillance: source document review knowledge and skills
• Experience in aggregate data analysis, interpretation and synthesis
• Good clinical and scientific judgment
• Clinical and/or medical research experience
• Understanding of methods of qualitative and quantitative safety data analysis

What you can expect of us

As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, well support your journey every step of the way.

The expected annual salary range for this role in the U.S. (excluding Puerto Rico) is posted. Actual salary will vary based on several factors including but not limited to, relevant skills, experience, and qualifications.

In addition to the base salary, Amgen offers a Total Rewards Plan, based on eligibility, comprising of health and welfare plans for staff and eligible dependents, financial plans with opportunities to save towards retirement or other goals, work/life balance, and career development opportunities that may include:

• A comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts
• A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan
• Stock-based long-term incentives
• Award-winning time-off plans
• Flexible work models where possible. Refer to the Work Location Type in the job posting to see if this applies.

Application deadline

Amgen does not have an application deadline for this position; we will continue accepting applications until we receive a sufficient number or select a candidate for the position.

Sponsorship

Sponsorship for this role is not guaranteed.

In any materials you submit, you may redact or remove age-identifying information such as age, date of birth, or dates of school attendance or graduation. You will not be penalized for redacting or removing this information.

As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other and live the Amgen values to continue advancing science to serve patients. Together, we compete in the fight against serious disease.

Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or any other basis protected by applicable law.

We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.